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A Phase Ia/Ib Clinical Study of HIV Entry Inhibitor CPT31:Single and Multiple Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adults anAdults with HIV

Award Number: U44AI095172
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/10/2011
PERIOD OF PERFORMANCE END DATE: 03/31/2023

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A Phase Ia/Ib Clinical Study of HIV Entry Inhibitor CPT31:Single and Multiple Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adults anAdults with HIV - SUMMARY HIV/AIDS remains a formidable global epidemic, with ~37 million people infected (including ~1.1 million in the US) and about one million AIDS-related deaths in 2017 (UNAIDS, CDC). Despite the efficacy of modern combination anti-retroviral therapy (cART), side effects and drug resistance remain serious obstacles to achieving optimal care, and poor adherence is a key factor in treatment failure. Thus, there is continued demand for well-tolerated HIV inhibitors with novel mechanisms of action and stronger barriers to resistance. HIV specialists are especially enthusiastic about the potential of long-acting therapies to minimize side effects, enhance efficacy, and delay resistance through improved compliance. Navigen has identified a novel, protease-resistant D-peptide HIV entry inhibitor, CPT31, with these desired characteristics and has advanced it through preclinical development. CPT31 addresses many of the limitations of current cART and has proven to be well tolerated and highly efficacious for both indications in non-human primates (NHPs), making it an ideal candidate for both therapy and PrEP. Additionally, CPT31’s PK makes it amenable to monthly and perhaps quarterly dosing (with depot formulation). In this grant application, we will partner with Johns Hopkins University to conduct a Phase Ia/Ib safety, tolerability, pharmacokinetics, and pharmacodynamics study of CPT31. The study will include three stages: 1) single ascending dose (SAD) in healthy volunteers, 2) multiple ascending dose (MAD) in healthy volunteers, and 3) MAD in HIV positive patients classified as Group 1 under the FDA guidance for industry. This study will enable Navigen to determine whether CPT31 has the characteristics that warrant continued clinical studies and further investment.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	NAVIGEN INC	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	10	1/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,000,000 )
2022	2022	NAVIGEN, INC.	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	001	10	4/7/2022	NON-COMPETING CONTINUATION	$1,000,000
2022	2020	NAVIGEN, INC.	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	8	3/31/2022	COMPETING CONTINUATION	$0
														Subtotal = $1,000,000

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	NAVIGEN, INC.	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	9	3/30/2021	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $1,000,000 )
2020	2020	NAVIGEN, INC.	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	000	8	4/24/2020	COMPETING CONTINUATION	$1,000,000
2020	2020	NAVIGEN, INC.	675 S ARAPEEN DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Allergy and Infectious Diseases Research	001	8	4/30/2020	COMPETING CONTINUATION	$0
														Subtotal = $1,000,000

Grand Total All Awards = $3,000,000

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A Phase Ia/Ib Clinical Study of HIV Entry Inhibitor CPT31:Single and Multiple Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adults anAdults with HIV

Award Number: U44AI095172

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/10/2011

PERIOD OF PERFORMANCE END DATE: 03/31/2023

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